We need avoidance of conflict of interest, not management: ASHA response to FSSAI’s draft guidelines for working with private sector
From: Kisan Swaraj <firstname.lastname@example.org>
Date: Fri, Oct 25, 2019 at 11:51 AM
Subject: ASHA’s Feedback on FSSAI’s draft guidelines on “Working with the Private Sector”
Cc: <email@example.com>, <firstname.lastname@example.org>, <email@example.com>, <firstname.lastname@example.org>
The Executive Director (Compliance Strategy)
Food Safety & Standards Authority of India,
Food and Drug Administration Bhawan,
Kotla Road, New Delhi 110002.
Sub: FSSAI’s draft guidelines on “Working with the Private Sector”, dated 4th Oct. 2019 (File No. 13 (36) 2019/Guidelines on Private Companies/RCD/FSSAI) for public feedback by 25th October 2019
Greetings! Alliance for Sustainable & Holistic Agriculture is a national network of individuals and organisations committed to improving agricultural livelihoods sustainably and to address food systems/ policy related issues (safety, diversity, nutrition, sovereignty etc.).
At the outset, we would like to state that it is high time that the Food Safety and Standards Authority of India (FSSAI) has guidelines in place for “Working with the Private Sector” and addressing issues of serious and objectionable conflict of interest in food safety regulation in the country. We also state strongly that the guidelines should not be about “management” of conflict of interest, but clearly about “avoidance” of conflict of interest.
Other than civil society groups writing to the FSSAI and the Health Ministry about such conflict of interest (for example, this letter from the Coalition for a GM-Free India http://indiagminfo.org/
In 2011, the Hon’ble Supreme Court of India was assured by FSSAI that scientific panels of the Food Safety and Standards Authority of India FSSAI will have only independent scientific experts in consonance with the section 13(1) of the FSSAI Act 2006. However, despite the statute being very clear and specific about “independent” scientific experts as well as independent safety assessment processes, the regulators have not implemented the law in letter and spirit.
What is alarming is that the food industry infiltrates the regulatory system in numerous ways, but also lures the top regulators into its own lobbying bodies, and that our regulators are willingly joining such bodies. These industry bodies or platforms have been created specifically to influence regulation and policy making and FSSAI must indeed be aware of this. Formal partnerships with Indian food companies and industry lobbies (international as well as Indian) like IADSA, FFRC or ILSI are therefore outright objectionable.
In many sections of the so-called draft guidelines, it appears that these are not really guidelines, but an attempted justification around why industry representatives are to be included in India’s position-development and not just consulted (for eg., in the Codex Shadow Committees).
Influencing standards, safety assessment regimes and rule-making is the real intention of the food industry in all its different forms of association with the food safety regulator, and this needs to be avoided fully.
ASHA believes that before new guidelines are formulated and implemented, the following should be taken up by FSSAI to actually exhibit that these new efforts are not an eyewash:
- Individuals backed by the food industry cannot be members of FSSAI scientific panels. At least 7 of the scientific panels of FSSAI have Chairs or Members from ILSI (International Life Sciences Institute) or its Indian branch, names listed in brackets. These include:
o Scientific Panel on Method of Sampling and Analysis – Dr.Sushil Kumar Saxena
o Scientific Panel on Food additives, Flavourings, Processing Aids and Materials in contact with food – Dr Debabrata Kanungo
o Scientific Panel on Contaminants in the food chain – Dr.Sushil Kumar Saxena
o Scientific Panel on Pesticides and Antibiotic Residues – Dr Debabrata Kanungo
o Scientific Panel on Labelling and claims/advertisements – Dr. Amarinder SinghBawa
o Scientific Panel on functional foods, nutraceuticals, dietetic products and other similar products – Dr B Sesikeran
o Scientific Panel on nutrition and fortification – Dr RK Marwaha
Similarly, anyone associated with International Alliance of Dietary/Food Supplement Associations (IADSA), or backed by CII-Jubilant Bhartia Food and Agriculture Centre of Excellence (FACE), or from Food Fortification Resource Centre (FFRC) or from CII-HUL Initiative on Food Safety Sciences (CHIFFS) or Global Food Safety Partnership (GFSP) or Resource Centre for Health Supplements and Nutraceuticals (RECHAN)or Global Alliance for Improved Nutrition (GAIN) or Infant and Young Child Nutrition Council or similar outfits need to be removed from any position in the regulatory regime urgently, except for the positions provided for, in the statute itself (Food Safety and Standards Act 2006).
- FSSAI as a body needs to back out from associations with these bodies as well. All officials of FSSAI who are on industry lobby panels need to withdraw from those positions immediately. This includes CEO of FSSAI.
- All formal agreements of FSSAI with the food and beverages industry (both associations or with particular companies like Hindustan Lever or ITC) that it seeks to regulate should be immediately terminated. FSSAI partnering with food companies like PepsiCo India Holdings Pvt Ltd and Emami on its Safe & Nutritious Food programme in schools as a CSR partner is a situation which must end immediately. PepsiCo promoting FSSAI’s Safe & Nutritious Food programme in schools should be stopped immediately. Allowing ILSI to be part of FSSAI’s Food Safety Knowledge Assimilation Network should be disallowed immediately.
FSSAI has partnered with Coca Cola, ITC, PepsiCo, Kellogg India Private Limited, KFC India amongst many other corporates which promote and sell unhealthy food for Eat Right India for Sustainable Living. Whilst working with such firms to get them to reduce plastic packaging or changing some of their ingredients to make it less unhealthy is a welcome step, a programme where FSSAI partners with such firms called Eat Right India for Sustainable Living gives an impression to wider public is that these firms sell healthy/right food which cannot be further from truth.
- FSSAI’s regulatory staff trainers’ list has individuals employed/associated with industry institutions such as Coca Cola, Kellogg India, Marico Limited, CII-Face, Mondelez India Foods amongst others. Such individuals must be removed from FSSAI’s regulatory staff trainer list.
- Civil society networks have also pointed out in the past about persons involved in GM crop development are part of scientific panels, and they need to be removed urgently.
Coming to the draft guidelines on which public comments are being sought:
- The guidelines, we noted, are covering (1) Institutional Framework (Food Authority and Central Advisory Council; Scientific Committee, Scientific Panels and Working Groups; Standards Review Groups; Codex Shadow Committees; Technical Panels and Method Review Groups); (2) Food Testing Laboratories; (3) Training and Capacity Building; (4) Third Party Accreditation/Audit; (5) Association with Specialised Centre established by Industry or Industry Associations; (6) Outreach and Awareness; and (7) Food Safety Mitra ‘Friends of Food Safety’.
As stated earlier, these are mainly about managing conflict of interest and not sincerely purging the system of conflict of interest, since it appears that FSSAI has already decided that “the participation of private entities is encouraged”.
- It appears that in FSSAI’s current thinking, it is alright as long as a private co-partner does not promote a particular brand or interest. We believe that such thinking is inadequate and incorrect. The concern should be about the regulatory regime itself being collectively shaped by vested interests. Given that FSSAI attempts a culture of self-compliance, it is all the more important to maintain independent oversight and monitoring in regulation. What is needed clearly is a clear demarcation of where constant consultations and reviews are needed, and where collaborations are needed, if at all.
(1) PRIVATE SECTOR AND (INFILTRATION INTO) THE INSTITUTIONAL FRAMEWORK
- For the Food Authority and Central Advisory Committee composition (Guideline (a)), given that the statute itself has provisions for representation of industry concerns (Sec.5 and 11), the issues and concerns of the food industry do get space and representation already. Declaration, and recusing from decision-making if needed, as proposed in the draft guidelines, are acceptable modalities here.
- However, the same will not work in Scientific Committee, Scientific Panels and Working Groups (Guideline (b)). Here, it is absolutely essential to have only “independent” scientific experts. Cool off period if an expert is from the industry of at least 3 years (a particular company, or industry association, or industry-established research centre etc.) is essential, other than an undertaking and declaration of interest. Similar is the case with Undertaking to act independently of any external influence, or declaration of commitment and an annual declaration of interests, and a declaration at each meeting. This is not adequate without prior cooling off period, and subsequent cooling off period too. Apart from this, the formats used for declaration assume significance given that they need to accurately capture the current conflict of interest of any particular person, in numerous ways. The only way to bring in independent decision-making is to prevent the entry of any conflict of interest. Multi-member, multi-stage decision making also will not work as an inbuilt mechanism to prevent biases, if the regulatory regime is designed to be slack, consequent to the induction of vested interests or consequent to an already slack safety assessment regime put into place.
- Standards Review Groups (Guideline (c)) can, and should be independent of members nominated by the industry associations. However, adequate number of consultations can be had with industry associations and multiple representatives of the industry. In fact, Standards Review Groups can be dissolved completely, only to form Standards Review processes, with the involvement of reputed consumer rights and civil society organisations along with independent experts and members of the public who used to be associated with industry earlier.
- In the Codex Shadow Committees (Guideline (d)), we note that other than a justification as to why industry nominees should be part of such committees, no guideline has actually been proposed. We believe that industry representatives and nominees are not needed, and the development of India’s position on any issue under discussion at Codex can be formulated by seeking written feedback from the industry, and holding some consultations.
(2) PRIVATE SECTOR AND FOOD TESTING LABORATORIES
It is noted that the Food Authority notifies food testing laboratories under Section 43 (1) of the Act, as per the regulations notified in 2018 for such Recognition and Notification of Laboratories, and that private labs which are NABL-accredited are also recognised and notified. NABL accreditation, only authorised/notified Food Analysts to be involved in testing regulatory samples, disallowing such private labs from testing any sample of any food business related to it, or having commercial interest in the laboratory are some initial steps to prevent conflict of interest. Going beyond this, here too, a Periodic Declarations are to be obtained about the funding that went into setting up of the private lab and the food industry interests of the funders and the current management’s connections with any constituent of the food and beverage industry. Samples should be kept intact, in case new information emerges about a private laboratory after test reports are already made, to be further tested in another independent lab. About FSSAI encouraging laboratories under the PPP framework, it is not clear what this means – if it is about setting up new laboratories, it is unclear why independent public sector laboratories cannot be set up with more investments made on the same.
(3) PRIVATE SECTOR AND TRAINING & CAPACITY BUILDING
To fulfil the responsibility mandated in the Act with regard to training of FBOs, FSSAI initiated a large scale training programme called Food Safety Training & Certification (FoSTaC), it is reported. It is also stated that such trainings are based on FSSAI-prescribed course content/curriculum, and that they follow a system of empanelment of training partners, calling for expression of interest, trainings by trainers duly certified by FSSAI and assessment by third party evaluators.
Creation of training modules, course content/curriculum and the course materials also need to be independent, without any biases creeping in. Representatives of consumer organisations and other public interest bodies may be asked to examine and scrutinise the training content before such modules are cleared in the system.
Trainings of regulatory staff and laboratory personnel also need to be examined and scrutinised periodically by independent experts including the selection of resource persons – a wide range of resource persons, primarily from the public sector, have to be empanelled first.
Centres of Excellence for training of laboratory personnel should be first created in the public sector, before collaborations with private enterprises are thought of.
(4) THIRD PARTY ACCREDITATION/AUDIT
Quality assurance certification through APEDA/NCOF certification systems, NABCB accredited institutions, NABL-accredited laboratories, FBO auditing through accredited auditors etc., seem to be systems already in place, with rules and procedures laid down for declarations, empanelment, penal/remedial actions for debarring audit agencies etc. Without studying the existing systems further, we are not in a position to comment meaningfully on this.
(5) FSSAI ASSOCIATION WITH SPECIALISED CENTRES ESTABLISHED BY INDUSTRY OR INDUSTRY ASSOCIATIONS
We believe there is no need for FSSAI to associate itself with such associations or specialised centres and to set up interface committees etc. Any such interface can be through formal consultations that FSSAI’s relevant bodies conduct, while the industry can indeed have such bodies functioning outside the formal scope of the regulatory regime, to constantly improve their own standards, and for voluntary codes to be improved for self-regulation and compliance.
(6) OUTREACH AND AWARENESS
ASHA does not subscribe to the belief that FSSAI seems to hold, that mass outreach activities are possible only with private participation and initiative. Dissemination of information and education, on behalf of FSSAI, by the private sector is a clear No-No. Across different ministries and departments of India, mass outreach indeed happens without the approach that FSSAI is adopting. This “guideline” once again is only a justification for something that FSSAI is already doing in the garb of a proposed guideline. If such outreach and awareness has to be created, FSSAI may consider collaborating with independent, non-profit neutral civil society/consumer organisations or NGOs not related to food industry in any manner. The food industry can, and should independently deploy its Corporate Social Responsibility to take up mass outreach and awareness in their own manner without any formal collaborations with FSSAI, and existing or strengthened systems of regulating information dissemination can be used by FSSAI and citizens where needed.
(7) FOOD SAFETY MITRA/‘FRIENDS OF FOOD SAFETY’
ASHA will try to respond to the evolving of the FSM concept once the detailed mechanics of the scheme are developed and shared for public feedback.
We conclude by asking FSSAI to set up a grievance redressal mechanism, for addressing any violations of these guidelines, which should lead to prompt interventions and positive action to rid the system of conflict of interest – such a response has not been forthcoming so far. WE believe that all declarations and all MoUs related to FSSAI should be put out into the public domain.
On behalf of ASHA Steering Group
i. Mr Pawan Agarwal, CEO, FSSAI
ii. Ms Rita Teotia, Chairperson, FSSAI
iii. Ms Preeti Sudan, Secretary, Ministry of Health & Family Welfare
iv. Dr Harsh Vardhan, Minister for Health & Family Welfare
This letter is endorsed by:
1. Akash Naoghare, Nagpur Beejotsav, Nagpur
2. AnanthaRaman, Tula, Chennai
3. Ananthoo, Safe Food Alliance, Tamil Nadu
4. Anshuman Das, BhoomiKa and Welhungerhilfe, India
5. Aruna Rodrigues, Sunray Harvesters, Mhow, Madhya Pradesh
6. Ashalatha, MAKAAM Telangana, Hyderabad
7. Balaji Sankar, Tharcharbu Iyakkam, Sirkali
8. Bhanuja Ch, REDS, Andhra Pradesh
9. Caxton Christ, concerned citizen
10. Clarence Pinto, concerned citizen
11. Desi Bihan Surakhya Mancha, Odisha
12. Dr Arun Gupta (MD Ped), Central Coordinator BPNI, Regional Coordinator, IBFAN South Asia, MD, World Breastfeeding Trends Initiative Global Secretariat
13. Dr J Devika, Professor, Centre for Development Studies
14. Dr Mohan Rao, former professor, centre of Social Medicine and Community Health, JNU, New Delhi, currently an independent public health researcher in Bangalore.
15. Dr Nupur Chowdhury, Assistant Professor of Law, Jawaharlal Nehru University, New Delhi
16. Dr Radha Mohan, retd Professor and former Information Commissioner, Odisha
17. Dr Ram Aditya, retd. Professor and independent natural health educator
18. Dr Rukmini Rao, Gramya Resource Centre for Women, Hyderabad
19. Dr Rupal Dalal, MD IBCLC, Adjunct Associate Professor, Dept of CTARA, IIT Bombay; Director of Health, Shrimati Malati Dahanukar Trust, Shrirampur, India
20. Dr Seema Purushothaman, Azim Premji University, Bangalore
21. Dr Sujatha Byravan, Chennai, Former President of the Council for Responsible Genetics, Cambridge, Massachusetts.
22. Dr Sultan Ismail, PhD, DSc, Soil Biologist and Ecologist
23. Dr Suman Sahai, Gene Campaign
24. Dr Thara KG, Former Head, Disaster Management Centre and Member Secretary, State Disaster Management Authority, Kerala
25. Dr V Jeevanantham, Tamilnadu Green Movement, Tamil Nadu
26. Fatima Burnad, Tamil Nadu Women’s Forum, Tamil Nadu
27. G R Vora, concerned individual and ‘Member of Petition Group’, Mumbai
28. Gaurang Motta, Mumbai Agriculture Study Circle, Mumbai
29. Gopi Deva, OFM, Chennai
30. Himakiran Anugula, Thondaimandalam Foundation, Chennai
31. Kavitha Kuruganti, ASHA, Bangalore
32.Kiran Vissa, Rythu Swarajya Vedika, Telangana and Andhra Pradesh
33. Krishna Kumar, concerned citizen
34. Kumar, Vanagam, Tamil Nadu
35. Nachiket Udupa, Concerned Citizen, Delhi
36. Nammalvar ecological research and training centre – L. Engals raja
37. Natabara Sarangi, Organic Farmers and Traditional Rice Seed Conservator
38. Pamayan, Adisil Cholai, Madurai
39. Paschim Odisha Krushak Sanghtana Samanwya Samiti
40. Praveen Kumar Gaur, Farmer, Kharangna Gode, Wardha, Maharashtra
41. R Manohar, Regional Coordinator, Human Rights Defenders Alert (HRDA) India
42. R Selvam, Tamilnadu Organic Farmers Federation, Tamil Nadu
43. Radhika Rammohan, reStore
44. Radhika Rammohan, Restore, Chennai
45. Raja Sankar, Sriram Foods / Madhu Farms, Pollachi, Coimbatore
46. Rajeev Kohli, Swadeshi Haat Gurdaspur, Punjab
47. Ramasubramanian Oruganti, Consultant FAO, Director Samanvaya Social Ventures, Senior Consultant, Sustainable Livelihoods Institute
48. Ravi Badri, social worker and concerned citizen, Rajasthan
49. Reena Ginwala, Soul Spaces and Kabir Saamagri, Pune, India
50. Rohit Parakh, India for Safe Food
51. Shanthi Elangovan, responsible citizen and consumer
52. Subbu, Thamilaga Vivasayegal Sangam, Erode
53. Subha Bharadwaj, Organic Terrace Garden, Chennai
54. Sudipto Banerjee, Sustainable Food Enthusiast, New Delhi
55. Sundarrajan G, Poovulagin Nanbargal, Tamil Nadu
56. Traditional Seeds Conservation Centre, Kalasapakkam, Thiruvannamalai
57. Umendra Dutt, Kheti Virasat Mission, Punjab
58. Usha Soolapani, Thanal, Kerala
59. Uzramma, Malkha Trust, Hyderabad
60. Velga Vasudev, Safe Food Enthusiast, New Delhi
61. Vikram Kumar, concerned citizen